Winncare PAC Ltd

Winncare PAC Ltd specialises in mobility and pressure-relieving support products. Their portfolio includes patient hoists for safe lifting, foam cushions for seating comfort, and mattress systems designed for clinical and home care. These systems range from adjustable air-cell mattresses to anti-vandal mattresses for high-traffic environments, as well as modular components like spacers and trolley-mounted mattresses. All products focus on patient mobility, comfort, and clinical safety.

Winncare PAC Ltd is based in the United Kingdom, which means its devices are subject to EU medical device regulations. Since all listed devices fall under Class I classification—reserved for low-risk, non-invasive products—they must comply with EU MDR/AMDR requirements, including registration in EUDAMED, the EU’s medical device database. The UK’s alignment with EU standards ensures consistency in regulatory oversight.

Yes, Winncare PAC Ltd’s devices are recorded in EUDAMED, the official EU database for medical devices. This registry is critical because it provides transparency on authorised products, their classifications, and regulatory status. For healthcare providers, it confirms compliance with EU safety standards, while for manufacturers, it ensures traceability and market access under EU medical device laws.

All of Winncare PAC Ltd’s devices are classified as Class I, the lowest risk category under EU regulations. This classification applies to non-invasive products like cushions, mattresses, and hoists that pose minimal risk to patients. Class I devices typically require basic conformity assessments (e.g., manufacturer declarations) but do not need third-party certification unless they incorporate measuring functions or are reusable surgical instruments.